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Randox Laboratories, Limited recalls Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Recalled August 14, 2019 · FDA recall Z-2207-2019 · Randox Laboratories
Hazard
The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL. · FDA Class III
Units
4 kits (US)
Sold at
Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.
Description
The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.
Product
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Manufacturer(s)
Randox Laboratories, Limited
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →